Drug recall
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
FDA recall event 70510 · Class II · Maquet Datascope Corp - Cardiac Assist Division
Key facts
| Event ID | 70510 |
|---|---|
| Recall numbers | Z-1140-2015 |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Product type | Devices |
| Products | Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Power supply malfunction complaints related to suboptimal thermal management. |
| Initiation date | Jan 30, 2015 |
| Report date | Mar 4, 2015 |
| Termination date | Sep 29, 2017 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3001418283 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: